Improved nutritional tablet

ABSTRACT

To improve the solubility and the speed of dissolution of nutritional tablets comprising protein, fat and carbohydrates, dietary fibers are included in the nutritional tablets.

FIELD OF THE INVENTION

The present invention is in the field of nutrition in solid form, whichis for drinking upon dissolution.

BACKGROUND OF THE INVENTION

Nutrition in solid form, in particular in the form of a tablet, has theadvantage of being easy in use by the consumers. For example inpreparing infant milk formulae the scooping of powders is difficultpotentially leading to dosing mistakes and/or to spilling of the powder.Therefore there is a need for tablets for nutritional formulae that arenot in a ready to feed format. Since tablets are also a convenienceproduct, the tablets should be convenient for use. This means that thetablets should be strong enough to be transported in a box or flow wrapand handled by the consumer, while at the same time the tablets shoulddissolve quick enough, i.e. comparable with the corresponding powderformulae. When preparing a tablet with a nutritional composition, theproblem is to strike the balance between the hardness and friability ofthe tablet and the solubility of the tablet.

In the art when looking at tablets in general, dissolution rate has beenaddressed by using an effervescent system e.g. bicarbonate that helps todissolve the tablet quickly. However, such systems cannot be used infood compositions since this would lead to lots of practical issues likefoam formation, increase in salt content, etc. Other approaches usespecific powder features like loose density, and specific free fatcontent and compressing circumstances. Drawbacks are in thesignificantly limited processing possibilities for making tablets,potentially leading to increased cost price.

EP 1048216 discloses tablets including tablets based on infant formula.

EP 1769682 discloses tablets with a specific porosity and free fatcontent wherein the tablets contain dairy proteins.

U.S. Pat. No. 3,241,975 disclosing tablets prepared from dairy products

The inventors of the present invention therefore tried to find analternative for preparing a nutritional tablet.

SUMMARY OF THE INVENTION

It is known in the art that it is difficult to make a tablet comprisinga nutritional composition comprising dairy protein and fat. The presentinventors when making compressed infant formula and medical foods in theform of tablets were challenged with the problem that the tablets needto dissolve quickly and completely, while on the other hand the tabletsshould be hard enough, with a high breaking strength, to withstandnormal handling in a package or flow wrap without falling apart orbreaking. Thus when preparing a tablet with a nutritional composition,especially comprising as main ingredients protein, fat andcarbohydrates, the problem is to find the balance between the strengthof the tablet and the solubility of the tablet.

Surprisingly the inventors found that dietary fibers can be used as anutritionally acceptable ingredient to improve the solubility and thespeed of dissolution of nutritional tablets comprising protein, fat andcarbohydrates. Thus when dietary fibers are used for preparingnutritional compositions in tablet form, the solubility of the tablet isimproved while having a sufficient hardness.

DETAILED DESCRIPTION OF THE INVENTION

The invention thus concerns a composition comprising fat, protein andcarbohydrates, wherein the carbohydrates comprise dietary fibers, andwherein the composition is compressed in the form of a tablet with ahardness of 15 N to 250 N when tested in a hardness tester wherein aforce is applied horizontally on the tablet with a constant test speedof 2 mm/s. Hereafter, this is also referred to as the (present)composition in the form of a tablet.

In the representative example 1 it can be seen that the formula preparedwith dietary fibers have in improved solubility when compared to exactlythe same formula wherein the dietary fibers are absent.

Also other examples showed that dietary fibers improve the solubility ofcompressed powders.

In a preferred embodiment the composition in the form of a tabletaccording to the present invention comprises protein, fat andcarbohydrates wherein the carbohydrates comprise at least 1 weightpercent (wt %) dietary fibers based on the total weight of thecomposition. Preferably the composition in the form of a tabletcomprises dietary fibers in a range between 1 and 15 wt % of the totalcomposition.

As mentioned before, especially for infant formula, where parents areused to dissolve powder products for preparing a bottle of formula, thedissolution time is very important and is preferably be in the rangesimilar to the powder product. Preferably the dissolution time is notlonger than 60 seconds upon shaking. Therefore the present invention isparticularly preferred for nutritional formulae and in particular forpreparing an infant formula in tablet form or a medical food in tabletform. In one embodiment, the composition in the form of a tabletaccording to the present invention is an infant formula. In oneembodiment, the composition in the form of a tablet according to thepresent invention is a medical food.

The present invention also concers the use of the present composition inthe form of a tablet for the dietary management of growth in infantsbetween 0 and 36 months. This can also be worded as a method for thedietary management of growth in infants between 0 and 36 months,comprising administering the present composition in the form of atablet. Also this can be worded as the present composition in the formof a tablet for use in the dietary management of growth in infantsbetween 0 and 36 months. The invention cal also be worded as the use ofa composition comprising fat, protein and carbohydrates, wherein thecarbohydrates comprise dietary fibers for the preparation of anutritional composition in the form of a tablet with a hardness of 15 Nto 250 N when tested in a hardness tester wherein a force is appliedhorizontally on the tablet with a constant test speed of 2 mm/s, for usein the dietary management of growth in infants between 0 and 36 months.

The invention also concerns the use of dietary fibers for improving thedissolving time of compressed powders comprising fat, protein andcarbohydrates, wherein the carbohydrates comprise the dietary fibers ina range between 1 and 15 wt % of the total composition.

Hardness or Breaking Strength

The standard method used for testing hardness of a tablet iscompression. The tablet is placed between two jaws that crush thetablet. The force applied to the tablet is measured and it is detectedwhen the tablet fractures. Preferably a tablet according to the presentinvention has a hardness between 15 N and 250 N using a Schleunigerhardness tester. The tablets are placed horizontally on the holder ofthe Schleuniger hardness tester and a force is applied horizontally onthe tablet with a constant test speed of 2 mm/s. In a preferredembodiment the tablet comprises at least 1 wt % dietary fiber and has ahardness in the range of 20 N to 250 N. Since the use of dietary fibersshortens the dissolving time harder tablets can be made. Harder tabletsare preferred since they are more stable during transport and handlingof the tablets. A more preferred hardness of the tablets is therefore inthe range of 25 N to 250 N, and even more preferred 30 N to 250 N whentested in a hardness tester wherein a force is applied horizontally onthe tablet with a constant test speed of 2 mm/s.

Methods for preparing tablets are known per se. The composition in theform of a tablet according to the present invention is preferablyprepared by compressing a powder. It is routine practice for one skilledon the art to prepare tablets by compressing powder, taking into accountthe desired strength of the tablet in relation to the degree ofcompression.

Dietary Fiber

According to the present invention not all sugars are capable ofimproving the solubility of the compressed nutritional powders. As canbe seen from example 1 wherein the infant milk formula with GOS andIcFOS is compared with the exact same product comprising lactose. Fromthis experiment it can be seen that dietary fibers GOS and IcFOS canimprove the dissolving time of the tablet. Preferably the presentcomposition comprises at least one dietary fibre selected from the groupconsisting of galactooligosaccharides, trans galactooligosaccharides,fructans, fructooligosaccharides, long chain fructooligosaccharides(IcFOS, e.g. inulin), short chain fructooligosaccharides (scFOS),xylooligosaccharides, palatinoseoligosaccharide, soybeanoligosaccharide, pectin, pectate, alginate, sialoglycans, fucoidan,fucooligosaccharides, and/or degradation products of dietary fibres.More preferably the composition according to the present inventioncomprises a mixture of galactooligosaccharide and fructans.

Protein

The present composition in the form of a tablet comprises protein. Anyprotein can be used in the composition in the form of a tablet accordingto the present invention. Vegetable protein, animal protein or mixturesthereof are equally effective. A preferred protein is however wheyprotein in an amount of at least 20 wt %, more preferably 50 wt % basedon total weight of protein, even more preferably at least 55 weightpercent (wt %) and even more preferably between 55 and 75 wt % based ontotal weight of protein. Protein includes all nitrogen sources such asfree amino acids, hydrolysates and intact protein.

In a preferred embodiment of the invention the composition in the formof a tablet comprises a relatively high amount of protein, preferably atleast 8% based on total calories, more preferably between 8 and 70%based on total calories of the composition in the form of a tablet isfrom protein. In a most preferred embodiment the protein is a fastabsorbing protein such as bovine whey protein, or protein hydrolysates.The present composition in the form of a tablet preferably comprises 7to 25 wt. % protein, more preferably 8 to 10 wt. %.

Nutritional Compositions Infant Formula in Tablet Form

The term infant formula according to the present invention is meant toinclude growing up milks and follow on formula for providing thecomplete daily nutritional requirements to a human subject with an agebelow 36 months, more preferably a human infant.

The present composition in the form of a tablet is a nutritionalcomposition and preferably comprises digestible carbohydrate. Preferreddigestible carbohydrates are lactose, glucose, sucrose, fructose,galactose, maltose, starch and maltodextrin. Lactose is the maindigestible carbohydrate present in human milk. The present compositionin the form of a tablet preferably comprises lactose. The presentcomposition in the form of a tablet preferably comprises 30 to 70 wt. %,more preferably 40 to 65 wt. % digestible carbohydrates. The presentnutritional composition in the form of a tablet preferably comprisesdigestible carbohydrate, wherein at least 35 wt. %, more preferably atleast 50 wt. %, more preferably at least 70 wt. %, of the digestiblecarbohydrate is lactose. The present composition in the form of a tabletpreferably comprises at least 30 wt. % lactose, preferably at least 40wt. %. Based on total calories the composition preferably comprises 30to 60% calories derived from digestible carbohydrates, more preferably40 to 60%.

The present composition in the form of a tablet comprises fat.Preferably the fat of the present composition in the form of a tabletprovides 35 to 60% of the total calories of the composition, preferablythe fat provides 40 to 50% of the total calories. The presentcomposition in the form of a tablet preferably comprises 10 to 40 wt. %,preferably 12.5 to 30 wt. % fat, more preferably 15 to 25 wt. % or morepreferably 19 to 25 wt. %.

Preferably the fat comprises the essential fatty acids alpha-linolenicacid (ALA), linoleic acid (LA) and/or long chain polyunsaturated fattyacids (LC-PUFA). The LC-PUFA, LA and/or ALA may be provided as freefatty acids, in triglyceride form, in diglyceride form, in monoglycerideform, in phospholipid form, or as a mixture of one of more of the above.Preferably the present composition in the form of a tablet comprises atleast one, preferably at least two lipid sources selected from the groupconsisting of rape seed oil (such as colza oil, low erucic acid rapeseed oil and canola oil), high oleic sunflower oil, high oleic saffloweroil, olive oil, marine oils, microbial oils, coconut oil, palm kerneloil and milk fat.

The present composition in the form of a tablet preferably comprisesfat, protein and digestible carbohydrate in the ranges as describedabove. The present composition in the form of a tablet preferablycomprises other fractions, such as vitamins, minerals, trace elementsand other micronutrients in order to make it a complete nutritionalcomposition. Preferably the composition in the form of a tablet isselected from the group consisting of an infant formula, follow onformula, toddler milk or formula and growing up milk, more preferablyform the group consisting of an infant formula and follow on formula.Infant and follow on formulae comprise vitamins, minerals, traceelements and other micronutrients according to international directives.

Preferably the fat provides 35 to 60% of the total calories, the proteinprovides 5 to 15% of the total calories and the digestible carbohydrateprovides 30 to 60% of the total calories of the composition in the formof a tablet. Preferably the present composition in the form of a tabletcomprises lipid providing 40 to 50% of the total calories, proteinproviding 6 to 12% of the total calories and digestible carbohydratesproviding 40 to 60% of the total calories of the composition. The amountof total calories is determined by the sum of calories derived fromprotein, lipids and digestible carbohydrates.

Preferably the composition in the form of a tablet according to theinvention comprises between 7 and 25 wt % protein, 30 and 70 wt %carbohydrates and 10 and 30 wt % fat based on the total weight of thecomposition. Preferably the composition in the form of a tabletaccording to the invention comprises 8 to 10 wt % protein, 55 to 65 wt %carbohydrates, and 15 to 25 wt % fat based on the total weight of thecomposition.

Medical Food in Tablet Form

Another preferred embodiment is medical food in tablet form. Medicalfoods can be complete nutritional products comprising fat, carbohydrate,protein, and vitamins and minerals. Food supplements comprisingingredients in lower or imbalanced quantities are also part of theinvention.

A specific problem related to medical foods is the relatively largequantities of unsaturated fatty acids they contain. These fatty acidsare known to oxidize due to presence of oxygen in the composition and/orhigh temperatures necessary to sterilize the composition. Oxidation ingeneral is a problem in the food industry determining to a large extentthe shelf life of a product. Oxidation of poly-unsaturated fatty acidsalso diminishes the nutritional value of the fatty acids. It is knownthat oxidation of fatty acids produces free radicals, which are believedto play a role in the development of cancer and other degenerativediseases. The present inventors discovered that when nutritionalproducts comprising fat wherein the fat comprises at least partlypoly-unsaturated fatty acids such as linoleic acid, EPA, DHA or AA theoxidation of these fatty acids is largely prevented when the compositionis in the tablet form. Therefore, a preferred composition in the form ofa tablet according to the present invention comprises poly-unsaturatedfatty acids (PUFA). Preferably the composition in the form of a tabletcomprises at least 1 wt. % poly-unsaturated fatty acids. In particularEPA and DHA are very sensitive to oxidation. Therefore in a preferredembodiment according to the present invention the composition in theform of a tablet comprises at least 0.1 wt % EPA or DHA or a mixturethereof, based on the total weight of the composition, even morepreferably between 0.1 and 5 wt % based on the total weight of thecomposition.

It has been found that the oxidation of PUFA becomes particularly aproblem for the taste when at least 1 wt % of the fatty acids is presentas EPA or DHA or a mixture thereof. Commercial preparations of EPA orDHA are often protected to oxidation by the addition of vitamin E. Thefishy off-taste of nutritional products containing EPA or DHA isparticularly bad when the composition contains more than about 1 wt %EPA or DHA based on the total dry weight of the composition. In apreferred embodiment according to the present invention of thecomposition in the form of a tablet therefore comprises protein, fat andcarbohydrates wherein the fat comprises at least 1 wt % EPA or DHA orboth based on the total weight of the composition, more preferably atleast 1.2 wt % and even more preferably at least 1.5 wt % and preferablynot more than 5 wt % EPA or DHA or a mixture thereof, based on totalweight of the composition. When the tablet is coated, e.g. by filmcoating techniques known in the art, the penetration of oxygen from theair will likely further decrease, resulting in even less oxidation ofthe unsaturated fatty acids. Therefore in a preferred embodiment thecomposition in the form of a tablet according to the present inventionis provided with a coating. Coatings that are suitable for nutritionaltablets are known to the skilled person.

EXAMPLES Example 1

In this example at a certain dissolving time the reconstitution of acomposition in tablet form according to the invention (active) versus acontrol was measured The active was an Infant milk formula comprising7.9 wt % dietary fiber, which was a mixture comprisinggalactooligosaccharides and long chain fructo oligosaccharides(GOS/IcFOS), and the control is the same formula wherein the GOS/IcFOSabsent.

Tablets were prepared as follows. A die is placed on a weighing tool andplaced on an analytical balance and a pre-determined amount of powder(active is 5.0 g, control 4.6 g) was weighted into the die. When enoughpowder was added, the lid of the die was placed on top of the die. Thedie was turned upside down and some pressure was applied to the puncheruntil the resistance of the powder was felt. The die was placed in amanual tablet press. The torch wrench was set onto the right amount ofapplied energy in Newton meters (Nm) and was placed on top of the manualtablet press. In this example the applied energy was 12 Newton meters.With the help of the torch wrench the puncher was lowered until themoment the pre-determined amount of energy was applied. The screw of thetablet press was turned in the opposite direction so the die could beremoved. The die was turned upside down and the lid was removed. Bypushing the piston inside the die the tablet was released.

The following method was used for determining the reconstitution:

-   -   a bottle of 240 ml was filled with 90 ml water of 40° C.    -   3 tablets were placed in the bottle and the bottle was closed    -   the bottle was placed in the bottle shaker and shaken for the        indicated time (10-60 seconds)    -   the content of the bottle was sieved over a sieve with a mesh        size of 600 μm    -   the milk was collected for further analysis    -   the bottle was rinsed 2 times with 180 ml water of 40° C. and        poured through the sieve, and the fluid that passed the sieve        was discarded    -   a picture was taken of every sieve

Every sample was tested with water of 40° C. and with different shakingtimes, from 10 until 60 seconds. The collected (first) milk was used todetermine the dry matter content.

Dry Matter:

The dry matter content was analysed with help of the “Monjonier” method.The reconstitution degree was calculated with the following formula:

Reconstitution(%)=(% dry matter content of sieved milk/% dry mattercontent of fully dispersed sample)*100.

FIG. 1 shows the influence of dietary fibres in tablets onreconsitution.

From the results it can be clearly seen that with a hardness between 15N and 30 N as measured using a Schleuniger hardness tester and a forcethat was applied horizontally on the tablet with a constant test speedof 2 mm/s the tablets with the dietary fibers have a much shorterdissolving time and a better reconstitution than the composition withoutdietary fibers. A 95% reconstitution is regarded as sufficientlydissolved.

Example 2 Comparison of Medical Food Powders with and without DietaryFibers on Reconstitution

Medical powders Code 120493 120805 Name Nutrison - Nutrison MF - controlactive Nutrient (per 100 ml Unit 100 ml 100 ml after dissolution) Energy(KJ) kJ 415 420 Energy (kcal) kcal 99 100 ProtEquiPD g 4.0 4..0Carbohydrate g 12.1 12.3 Sugars g 1.9 1.9 Glucose g 1.9 1..9 Lactose g<0.03 <0.03 Maltose g 1.4 1.3 PolySach g 10.0 10.1 Starch g 0.0 0.2Fibre g 0.0 1.5 (7.5 wt %) Soluble g 0.0 0.9 Insoluble g 0.0 0.6 FatTotal g 3.9 3.9 Porosity (%) 77 73 Reconstitution at 55% 81% 20 seconds

Tablets, prepared as described in example 1, wherein the food is amedical food. All ingredients were kept constant, except for the fibers.The hardness of the tablets was 16 N. The fibers in this compositioncomprise soy polysaccharides, resistant starch, inulin, Arabic gumcellulose and oligo fructose. As is clear from the result, thereconstitution at 20 seconds is much higher in the fiber containingproduct compared to the control product. Also at 60 seconds there was arelevant difference in reconstitution of 98% for the active and 91% forthe control product.

Example 3 Comparison Between Infant Milk Formula with and withoutGalactooligosaccharides and Inulin on Reconstitution

Name Control Active ProtEquiPD g 1.3 1.3 Carbohydrate g 8.1 7.9 Fibre g0.0 0.62 (5 wt %) Fat Total g 3.5 3.5 Porosity 36 38 Dissolution at 50%70% 20 seconds

Tablets were prepared as described in example 1. The hardness of thetablets was between 15 and 16 N. In this example a particularly strongeffect on dissolution was measured when comparing this infant formulawith and without GOS/inulin. Also at 60 second, the dissolution of theactive was 97% while the control was only 82%.

1. A composition comprising fat, protein and carbohydrates, wherein thecarbohydrates comprise dietary fibers in a range between 1 and 15 wt %of the total composition, in the form of a tablet with a hardness of 15N to 250 N when tested in a hardness tester wherein a force is appliedhorizontally on the tablet with a constant test speed of 2 mm/s.
 2. Thecomposition according to claim 1, which dissolves for 95% in less than35 seconds at 40 degrees Celsius.
 3. The composition according to claim1, which comprises between 7 and 25 wt % protein, 30 and 70 wt %carbohydrates, 10 and 30 wt % fat based on the total weight of thecomposition.
 4. The composition according to claim 3 comprising 8 to 10wt % protein, 55 to 65 wt % carbohydrates, and 15 to 25 wt % fat basedon the total weight of the composition.
 5. The composition according toclaim 1, wherein the fat comprises poly-unsaturated fatty acids.
 6. Thecomposition according to claim 5, wherein the fat comprises at least 1wt % poly-unsaturated fatty acids based on the total weight of thecomposition.
 7. The composition according to claim 6, wherein the fatcomprises at least 0.1 wt % EPA or DHA or a mixture thereof based on thetotal weight of the composition.
 8. The composition according to claim6, wherein the fat comprises between 1 and 5 wt % EPA or DHA or amixture thereof based on the total weight of the composition. 9.-10.(canceled)